FDA grants fast-track designation for Shire's lung drug

The FDA has granted Fast Track designation to Shire's SHP607 for the prevention of chronic lung disease in extremely premature infants.

SHP607, currently in phase 2 clinical development, is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 (IGF-1) and its most abundant binding protein, IGF binding protein-3 (IGFBP-3). IGF-1 plays an important role in the development of the fetus in the uterus.

The SHP607 Fast Track designation is supported by preclinical data and Phase 1 and 2 studies. The FDA's process is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

“We are pleased to achieve this regulatory milestone as we progress this very important clinical development program,” said Howard Mayer, Shire’s Head of Research and Development, ad interim. “There are no approved treatment options for chronic lung disease for premature infants, and we are aiming to change that."